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The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.
The therapeutic approach taken by this clinical trial may offer patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.
Patients giving written informed consent will undergo screening during the Pretreatment Period to determine eligibility for trial entry. The Pretreatment Period will include collection and recording of medical history, concomitant medications, baseline symptoms, previous therapies, and baseline assessments. The patient's baseline tumor burden will be recorded with radiological assessments, along with analyzing location and size of tumors to identify and characterize target tumor(s) that will be treated and/or followed during the clinical trial.
If confirmed eligible for the study, the patient will advance into the Treatment Period. During the Treatment Period, patients will receive a routine radiofrequency ablation (RFA), followed by an injection of investigational product (IP-001 for Injection) into the tumor. Patients can be treated every 6 weeks for up to 4 treatments with RFA + IP-001 for Injection.
A patient will move to the 6-month Follow-up Period when the patient has completed 4 treatment cycles or if the decision is made that no subsequent treatments will be administered. During the Follow-up Period, there will be a Follow-up Visit every 6 weeks for 5 visits, at disease progression, or prior to the start of a new antineoplastic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal Cancer (CRC) | Experimental | Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. |
|
| Non-Small Cell Lung Cancer (NSCLC) | Experimental | Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. |
|
| Soft Tissue Sarcoma (STS) | Experimental | Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.0% IP-001 for Injection | Drug | 4 mL 1.0% IP-001 for Injection following RFA every 6 weeks for up to 4 treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The assessment of safety will be based on incidence of adverse events. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC) | An iDC is defined as any complete response (CR or iCR), partial response (PR or iPR), or stable disease (SD or iSD) for 12 weeks according to iRECIST achieved during the trial until disease progression according to iRECIST, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Jorger, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
| Diane Beatty, PhD | Immunophotonics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cardiac & Vascular Institute | Coral Gables | Florida | 33146 | United States | ||
| University of Louisville Physicians, PSC |
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Open-label study with 3 Cohorts
There will be 3 study periods: a Pretreatment Period, a Treatment Period, and a Follow-up Period.
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|
| Up to 12 weeks |
| Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC) | A DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from start of treatment according to RECIST 1.1 achieved during trial until disease progression according to iRECEST, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Efficacy: Objective response according to iRECIST (iOR) | An iOR is defined as any complete response (CR or iCR) or partial response (PR or iPR) according to iRECIST achieved during the trial until disease progression according to iRECIST, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Efficacy: Duration of response according to iRECIST (iDOR) | An iDOR is defined as the time from the first documentation of iOR until disease progression according to iRECIST (iPD) or death from any cause. iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial discontinuation. | Up to 12 weeks |
| Efficacy: Progression-free survival according to iRECIST (iPFS) | An iPFS is defined as the time from treatment start until disease progression according to iRECIST (iPD) or death from any cause, whichever occurs first. | Up to 12 weeks |
| Efficacy: Objective response according to RECIST 1.1 (OR) | An OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 achieved during trial until disease progression, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Efficacy: Duration of response according to RECIST 1.1 (DOR) | A DOR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Efficacy: Progression-free survival according to RECIST 1.1 (PFS) | A PFS is defined as the time from treatment start until disease progression according to RECIST 1.1, or death from any cause, whichever occurs first. | Up to 12 weeks |
| Efficacy: Time to response according to iRECIST 1.1 (iTTR) | An iTTR is defined as the time from start of trial treatment until iOR according to iRECIST achieved during the trial. | Up to 12 weeks |
| Efficacy: Time to response according to RECIST 1.1 (TTR) | A TTR is defined as the time from treatment start until OR according to iRECIST achieved during the trial. | Up to 12 weeks |
| Efficacy: Disease-free survival (DFS) | A DFS is defined as the time from start of treatment that the patient survives without any signs or symptoms of cancer or death from any cause, whichever occurs first. | Up to 12 weeks |
| Efficacy: Overall survival (OS) | An OS is defined as the time from start of treatment until death from any cause. | Up to 12 weeks |
| Efficacy: OR of the injected lesions according to RECIST 1.1 | An OR of the ablated and injected (treated) lesions will be assessed using RECIST 1.1. | Up to 12 weeks |
| Efficacy: OR of the non-injected lesions according to RECIST 1.1 | An OR of the non-ablated and non-injected (untreated) lesions will be assessed using the RECIST 1.1 until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Efficacy: iOR of the injected lesions according to iRECIST | An iOR of the ablated and injected (treated) lesions will be assessed using the iRECIST until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Efficacy: iOR of the non-injected lesions according to iRECIST | An iOR of the non-ablated and non-injected (untreated) lesions will be assessed using the iRECIST until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. | Up to 12 weeks |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Institut Bergonie | Bordeaux | 33076 | France |
| Hospitalier Pitie-Salpetriere | Paris | 75013 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Johann Wolfgang Goethe-Univresitat Frankfurt/Main | Frankfurt | 60590 | Germany |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | 74078 | Germany |
| Munchen Klinik Bogenhausen | Munich | 81925 | Germany |
| IOSI Ospedale San Giovanni Bellinzona | Bellinzona | 6500 | Switzerland |
| Inselspital Universitatsspital, Bern | Bern | CH-3010 | Switzerland |
| Kantonsspital Graubunden | Chur | 7000 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| University College London Hospitals | London | W1T 7HA | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D003110 | Colonic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012509 | Sarcoma |
| D009369 | Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000718712 | N-dihydrogalactochitosan |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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